NCT07505004进行中（未招募）3 期
A Double-blind, Randomized Clinical Trial Evaluating the Efficacy and Safety of Vormatrigine in Adults With Focal Seizures
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 300
- 试验地点
- 7
- 主要终点
- To evaluate the efficacy of vormatrigine compared to placebo on focal seizure frequency in adults currently taking 1 to 3 ASMs
研究概览
简要总结
A multicenter, double-blind, randomized, placebo-controlled clinical trial to evaluate the efficacy and safety of vormatrigine in adults with focal seizures (POWER2)
详细描述
PRAX-628-322 (POWER 2) is a Phase 3, multicenter, double-blind, randomized, placebo-controlled clinical trial to evaluate the efficacy and safety of vormatrigine in adults with focal seizures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has a diagnosis of focal onset epilepsy according to the International League Against Epilepsy Classification of Epilepsy (2017).
- •Prior to randomization, past evidence by CT or MRI that has ruled out a progressive cause of epilepsy in the judgement of the investigator and/or in consultation with the medical monitor.
- •Participant must attest to be taking stable doses of 1 or up to 3 acceptable ASMs for at least 4 weeks prior to screening and during screening prior to Day
- •Has at least 4 countable focal onset seizures during the 4 weeks of Observation Period immediately prior to randomization with no more than 21 days seizure free during this period.
- •Seizure diary must be completed for ≥80% days in the Observation Period.
排除标准
- •Participant has had any of the following within the 12-month period preceding trial entry:
- •evidence of experiencing pseudo or psychogenic seizures
- •cluster seizures where the individual seizures cannot be counted
- •an episode of convulsive status epilepticus requiring hospitalization and intubation
- •seizures secondary to illicit drug or alcohol use
- •Seizures secondary to ongoing infection, neoplasia, demyelinating disease, progressive degenerative disease, metabolic illness deemed progressive, progressive structural lesion or encephalopathy.
- •Previously documented EEG which shows any pattern not consistent with focal etiology of seizures.
- •Planned epilepsy surgery during the course of the clinical trial.
- •History of any of the following:
- •neurosurgery for seizures <1 year prior to enrollment
- •radiosurgery <2 years prior to enrollment
- •neurostimulator placed <1 year prior to Screening
- •neurostimulator placed >1 year prior to Screening but settings have not been stable for at least 2 months prior to Screening
- •Active suicidal plan/intent in the past 6 months, or a history of suicide attempt in the last 2 years, or more than 1 lifetime suicide attempt, as confirmed by C-SSRS.
- •Has any significant ongoing disease, disorder, laboratory abnormalities, alcohol or drug abuse or dependence, environmental factor, or ongoing or recent history of any psychiatric, medical, or surgical condition.
- •Participants with a history of malignancy, myeloproliferative or lymphoproliferative disorders within the past 3 years are excluded.
- •History or presence of uncontrolled cardiac diseases including conduction and structural abnormalities.
- •Total bilirubin value >1.5×ULN; an ALT or AST value >3×ULN.
- •History of or active HIV infection or positive screening result for: HIV 1 or 2 antibodies. Evidence of active hepatitis B or hepatitis C infection, as determined by relevant screening assessments.
- •Has received any other experimental or investigational drug, device or other therapy within 30 days or 5 half-lives (whichever is longer) prior to Screening, or any prior use of gene or cell therapy.
- •Vigabatrin: Use in the last 5 years without stable visual fields tested twice over the 12 months after the last dose of vigabatrin.
- •Felbamate: If used as a concomitant ASM, patients must be on felbamate for at least 2 years, with a stable dose for 2 months prior to Screening. If a patient received felbamate in the past, it must have been discontinued 2 months prior to screening.
- •Significant allergic reaction to an ASM(s), including dermatological (e.g. Stevens-Johnson syndrome), hematological, or organ toxicity reactions. Severe reactions do not include simple maculopapular eruption and allergic rhinitis.
- •Is pregnant or breastfeeding at the time of Screening or has a positive serum pregnancy test at Screening or is planning to become pregnant during the clinical trial or prior to end of study visit.
- •Previous exposure to vormatrigine or known hypersensitivity to any component used in the vormatrigine formulation.
结局指标
主要结局
To evaluate the efficacy of vormatrigine compared to placebo on focal seizure frequency in adults currently taking 1 to 3 ASMs
时间窗: 12 weeks
Median percent change in monthly (28 days) focal seizure frequency from the Screening/Observation Period to the Treatment Period for vormatrogine compared to placebo.
次要结局
- To further evaluate the efficacy of vormatrigine compared to placebo on focal seizure frequency in adults currently taking 1 to 3 ASMs(12 weeks)
- To assess trends over time in efficacy of vormatrogine on focal seizure frequency(12 weeks)
- To assess the safety and tolerability of vormatrigine in adults with focal seizures(12 weeks)
研究者
研究点 (7)
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